ICI and Response in Autoimmunity


About this study

The primary aims of this study are to determine the immunopathology and molecular mechanisms of clinically-used PD-1 and PDL1 blockade mediated autoimmune diseases, and to investigate how dysregulation of PD-1 signaling contributes to IA-irAE and seronegative RA in human subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults, age ≥ 18 years.
  • Any concomitant malignancy being treated with any PD-1 inhibitor (pembrolizumab, nivolumab or cemiplimab) as monotherapy and the presence of inflammatory arthritis defined by:
    • provider documented inflammatory arthritis (meet 2010 EULAR/ACR classification criteria of RA) in one or more large or small joints; and at least one or more of the following:
    • elevated inflammatory markers;
    • supportive imaging and/or supportive synovial fluid analysis.

Exclusion Criteria:

  • Active infection.
  • Prior history of the rheumatic disease.
  • Any B cell depletion therapy.
  • PActive use of high (≥ 30 mg daily) of prednisone or steroid equivalent.
  • Clinical features suggestive of non-RA autoimmune rheumatic disease (e.g., lupus, Sjogren’s, psoriatic arthritis, etc.) or axial spondyloarthropathy.

Eligibility last updated 9/21/21. Questions regarding updates should be directed to the study team contact.


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hu Zeng, Ph.D.

Open for enrollment

Contact information:

Amber Woltzen


More information


Publications are currently not available

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